Diclofenac sodium

Product NDC
68788-7546
11-digit product format
687887546
Labeler code
68788
Product ID
68788-7546_b1770f42-6e36-4581-9d83-4b3b2c681e6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA206298
Marketing category
ANDA
Marketing start
2016-04-28
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
30 mg/g
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7546-1687887546011 TUBE in 1 CARTON (68788-7546-1) > 100 g in 1 TUBE1 tube2019-12-270000-00-00NoNoCurrent